Lower riskDrug recall · FDA · Published May 5, 2020
Exela Pharma Potassium Acetate Injection Recall: Short Fill Hazard
Exela Pharma recalls Potassium Acetate Injection vials with short fill risk. Affected lots from April 2021 may have incorrect potassium levels. Contact for return instructions.
“Exela Pharma Potassium Acetate Injection Recall: Short Fill Hazard.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37129-exela-pharma-potassium-acetate-injection-recall-short-fill-hazard. Based on FDA recall #D-1585-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1585-2020%22&limit=1).
The FDA announced on May 5, 2020, that Exela Pharma Sciences LLC voluntarily recalled Potassium Acetate Injection, USP 40 mEq/20 mL Single Dose Vials due to a short fill hazard. The recall affects 23,775 vials distributed nationwide and in Puerto Rico.
How to tell if you have it
Brand: Exela Pharma
Product: Potassium Acetate Injection, USP 40 mEq/20 mL (2 mEq/mL) Single Dose Vials
NDC: 51754-2001-4
Lot #: P0000471
Catalog #: 2020TS002
Exp Date: 04/2021
The hazard
The recall was initiated because the Potassium Acetate Injection vials contained a short fill, meaning they did not contain the full labeled volume of the drug. The FDA classified this as a Class III recall.
Context
GovInfoNow's records show Exela Pharma Sciences LLC has had seven other recalls on record since April 20, 2018. Recent brand recalls include an July 30, 2025 recall for Arsenic Impurity Risk and a March 7, 2025 recall for Lack of Sterility Assurance. Other recent recalls of similar products include an ICU Medical Potassium Chloride Injection recall due to Label Error (Oct. 29, 2025) and a Somerset Therapeutics Cisatracurium Besylate Injection recall for Subpotent Product Risk (Nov. 26, 2025).
How to tell if you have this one
Check for the lot number P0000471 on the vial label. The product was manufactured by Exela Pharma Sciences LLC in Lenoir, NC with an expiration date of April 2021.
Brand
Exela Pharma
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Vial Label
Look for the lot number P0000471 on the vial label to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 20 months after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-1585-2020 (May 5, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1585-2020 to see it in context.
Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.